Decision Date2020-11-20
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
TIPCAM1 Rubina Video Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K201526. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TIPCAM1 Rubina Video Endoscope System?
TIPCAM1 Rubina Video Endoscope System is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is Karl Storz Endoscopy America. The 510(k) number is K201526.
When did TIPCAM1 Rubina Video Endoscope System receive FDA 510(k) clearance?
TIPCAM1 Rubina Video Endoscope System received FDA 510(k) clearance on 2020-11-20, under 510(k) number K201526.
Who is the listed applicant for TIPCAM1 Rubina Video Endoscope System?
The FDA 510(k) record lists Karl Storz Endoscopy America as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TIPCAM1 Rubina Video Endoscope System?
The FDA product code for TIPCAM1 Rubina Video Endoscope System is GCJ.
Other records listing Karl Storz Endoscopy America as applicant
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.